在全球一片經濟不景氣的環境下，IMS 仍預測2009年全球藥品市場將會成長4.5-5.5％達到8200億美金，這顯示醫藥產業是一個值得投入的領域，台灣政府亦透過政策大力扶植醫藥產業發展，但是醫藥產業知識密集度高，投資金額高，開發時程長，失敗風險也高，台灣醫藥企業要如何擬定經營管理策略，將是影響成敗的重要因素。本文的目的是提出適合台灣藥廠的經營管理策略。
目前國際醫藥產業概況為，受到藥品安全事件影響，FDA對新藥審查越趨嚴格，加上研發新藥的投資成本越來越高，在得到明星新藥的速度追不上失去暢銷藥速度的壓力下，國際藥廠開始削減成本，將部分研發工作分工委外，進行企業聯盟與購併，以充實專利技術與產品版圖；由於眾多專利暢銷藥喪失專利，與政府鼓勵使用低價藥，學名藥市場備受看好。台灣醫藥產業多屬中小型企業，資金與研發能量不足，因此發展學名藥是第一項建議的策略。舊藥新用可以降低研發失敗風險與成本，是第二項建議的策略。技術移轉與授權是第三項策略，由外引進技術可以解決研發能力不足的問題，對外授權技術可以解決資金不足以撐完研發全程的問題，順應國際藥廠分工委外的趨勢，在醫藥產業生態鏈中合適的點進場與出場，能避免資金不足，減輕研發失敗的負荷。
學名藥廠如果能夠提早學名藥上市的時間就能增加獲利，熟悉簡易新藥申請程序、專利延長與資料專屬權保護規定對於學名藥上市時程的規劃有很大的幫助。美國最高法院對Merck v. Integra 的判決擴張藥物研發實驗實施免責權，鼓勵使用他人具專利的化合物進行與藥物審查相關的臨床前期試驗，有利於開發既有藥品的新用途，台灣的專利法相關規定亦在研討修法，希望結果對台灣藥廠採取舊藥新用的策略有所幫助。依據公司專長，研發能力強的公司可以將臨床前期獲得的專利技術授權給國際藥廠，而擅長臨床試驗的公司可以由外授權引進專利候選藥物在台灣進行臨床試驗，之後再對外授權，政府亦頒訂生技新藥產業發展條例，幫助企業應用技術移轉與授權找到生存的利基點。熟悉並活用法律知識是發展醫藥產業必備的工具。 / Even though people are worried about global economy recession, IMS still optimistically predicts that global pharmaceutical market will have 4.5 – 5.5 Percent growth in 2009, exceeding $820 billion. It means that pharmaceutical industry is a field worth investigating. The Taiwan government also provides fully support for pharmaceutical industry development through laws and regulations. However pharmaceutical industry is characterized for requiring high technology, lots of money, long developing time, and high risk of failure. The strategies pharmaceutical companies token will influence their fate to success or failure. The goal of this thesis is to propose suitable management strategies for Taiwan pharmaceutical industry.
After several drug safety related incidents in recent years, FDA becomes more conservative and blocks new drug approval. More over, it takes more money to investigate a new drug, and the speed of getting new drugs can not catch up the speed of losing patent of blockbuster drugs. Under such huge pressure, international pharmaceutical companies adopt strategies as outsourcing part of drug developing work to achieve cost down. They also conduct strategic alliances and mergers, which can enrich their patents and products portfolio. Generic drug has great market potential because of several blockbuster drugs losing patents and government favoring cheap drugs. Pharmaceutical companies in Taiwan are all small and medium size enterprises. Their research capacity and capital are insufficient. So the first recommended strategy is developing generic drugs. The second strategy is drug repurposing which can minimize the risk of failure. The third strategy is technology transfer and licensing. Complying with the trend of outsourcing, Taiwan companies can adopt technology transfer and licensing strategy and determine proper points to enter and out of the chain of drug development. Licensing-in can resolve the problem of insufficient research capacity. License-out can prevent shortage of money.
If a generic drug company can advance the timing to launch generic drug, it can earn more money. Thus well study of Abbreviated New Drug Applications, patent term expansion and data exclusivity can help plan market schedule. The Supreme Court decision in Merck v. Integra expands the protection of Safe Harbor which exempted from infringement all uses of patented compounds "reasonably related" to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs. Using patented compound in pre-clinical trials is exempted and it encourages drug developer to use patented compound owned by other companies to explore new usage. The patent ruling law experiment exemption in Taiwan needs further discussion and amended. Hope the result of amendment can help drug repurposing strategy in Taiwan. Research oriented company can license out patented result to big pharmaceutical companies, while companies good in clinical trial study can license in patented drug candidate and do clinical trial in Taiwan. Taiwan Government also set rules to encourage pharmaceutical companies to adopt technology transfer and licensing. Having well knowledge relating to drug approval and patent law is a must to run a successful pharmaceutical company.
| Identifer | oai:union.ndltd.org:CHENGCHI/G0093652001 |
| Creators | 賴怡臻, Lai,yi chen |
| Publisher | 國立政治大學 |
| Source Sets | National Chengchi University Libraries |
| Language | 中文 |
| Detected Language | English |
| Type | text |
| Rights | Copyright © nccu library on behalf of the copyright holders |
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